The Biomarkers Reference Laboratory (BRL) at the Johns Hopkins Medical Institutions (JHMI) will serve as a Network resource for clinical and laboratory validation of biomarkers, which includes technological development, assay standardization, and method refinement. The JHMI clinical laboratory is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified for the examination of human specimens for the diagnosis, prevention, or treatment of any disease. Based on our >20 years of experience in Clinical Chemistry, immunoassay, quality control, standardization, automation, proteomics, and cancer biomarkers, we have the unique ability to develop, optimize, scale-up, and automate diagnostic assays. If appropriate, we will consult or contract with the diagnostics industry in the development and scale up of reagent components. We have established an extensive network of academic and industrial collaborators. During the past 20 years, we have successfully conducted over 50 research projects funded by industry in the areas of cancer biomarkers and/or automated immunoassay systems including development, validation, and clinical studies leading to approval by the Food and Drug Administration (FDA). In addition, we are interested in performing a developmental study on the improvement of technologies for validation studies including bioinformatics, protein characterization, and multiplexing of biomarkers. The techniques that we propose include immunoassay, e.g. ELISA, protein chips e.g. SELDI technology, chromatography, e.g. HPLC and mass spectrometry for protein characterization. We propose forming a scientific advisory panel consisting of leaders from the industrial and academic communities to provide expert advice on specific issues pertaining to the development and validation of new cancer biomarkers. The advisory panel of experts includes clinical oncologists, urologists, cancer biologists, molecular and anatomic pathologists, and diagnostic industry scientists. We believe that this multidisciplinary approach offers the best solution for the identification, validation, and rapid commercialization of cancer biomarkers for clinical use.